UMIN ID: C000000022
Registered date:07/07/2005
Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Breast cancer |
| Date of first enrollment | 2005/07/01 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | chemotherapy capecitabine 1657mg/m2, cyclophosphamide 65mg/m2, q3w, 6cycles |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | Progression-free survival(PFS), overall survival(OS), adverse event |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 74years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1)Pregnant or breast feeding 2)Documented history of serious hypersensitivity reaction on the medical drugs 3)Patients who have experienced prior chemotherapy with capecitabine 4)With metastasis to the central nervous system 5)Serious underlying medical illness with heart, gastrointestinal tract, or infection |
Related Information
| Primary Sponsor | Kyushu Breast Cancer Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Non profit organization Clinical Hematology/Oncology Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 45-1, 7-chome, Nanakuma, Jonan-ku, Fukuoka Japan Japan |
| Telephone | 092-801-1011 |
| ktamura@fukuoka-u.ac.jp | |
| Affiliation | Kyushu Breast Cancer Study Group Executive Office |
| scientific contact | |
| Name | Shousyu Mitsuyama |
| Address | 1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyusyu Japan Japan |
| Telephone | 093-541-1831 |
| Affiliation | Kitakyusyu Municipal Medical Center Surgery |